Process For The Characterization Of Glatiramer Acetate

Abstract

The present invention is directed to process for characterization of Glatiramer acetate. The present invention further relates to process for characterization of Glatiramer acetate using size exclusion chromatography coupled with ultra performance liquid chromatography (SEC-UPLC) and high resolution mass spectrometry (HRMS). The present invention further provides statistical methods for characterizing and classifying Glatiramer acetate.

1 . A process for characterizing of Glatiramer acetate, the process comprising:
 a. subjecting a sample of Glatiramer acetate to size exclusion chromatography (SEC);   b. separating various fractions based on its size and subjecting the separated fractions through reverse phase chromatography to HRMS;   c. processing of electrospray ionized ion masses and obtaining deconvoluted masses for checking mass distribution pattern of Glatiramer acetate; and   d. characterizing the Glatiramer acetate using a statistical model.   
     
     
         2 . The process of  claim 1 , wherein the size exclusion chromatography is coupled with ultra-performance liquid chromatography and UV detector (SEC-UPLC-UV). 
     
     
         3 . The process of  claim 1 , wherein electrospray ionized masses data are generated by tandem mass spectrometric data such as ESI-QTOF. 
     
     
         4 . The process of  claim 1 , wherein step (c) is performed using Unifi software version 1.8.2.169 from Waters. 
     
     
         5 . The process of  claim 1 , wherein characterizing the Glatiramer acetate involves used of statistical models for the determination of mean mass, standard deviations, distribution curves, +1 and −1 deviations and mass categorizations for characterization of Glatiramer acetate. 
     
     
         6 . A process for characterization of mixture of polypetides, the process comprising using SEC-HRMS (Vion IMS-QTof) and statistical models for interpretations and illustrations wherein the mixture of polypetides consists of L-Alanine, L-Tyrosine, L-Lysine and L-Glutamic acid.